Digital Therapeutics Act Returns to Congress, Aiming for Medicare Coverage

2025-05-14 transformation

Washington, D.C., Wednesday, 14 May 2025.
The Access to Prescription Digital Therapeutics Act is reintroduced, potentially allowing Medicare to cover FDA-approved digital therapeutics, impacting coding, reimbursement, and digital healthcare innovation.

Legislative Momentum and Strategic Development

The reintroduction of the Access to Prescription Digital Therapeutics Act marks a significant milestone in digital health policy, representing five years of coordinated effort between industry stakeholders and policymakers [1]. The legislation, brought before the 119th Congress on May 7, 2025, builds upon previous initiatives, including the first PDT bill in 2022 and subsequent CMS engagement throughout 2023 [2]. This strategic development has been particularly crucial given that 45 states currently have less than 50% of their mental health professional needs met [3].

International Context and Medicare Implementation

The United States’ move toward digital therapeutic coverage follows successful international precedents, with Germany already implementing digital therapeutics for chronic diseases, mental health, and women’s health, while France, Japan, and South Korea are developing similar frameworks [3]. The legislation aims to establish a new category specifically for FDA-approved prescription digital therapeutics within Medicare [4]. Under the proposed framework, these digital therapeutics would undergo testing and regulation similar to traditional prescription medications, ensuring both safety and efficacy standards are met [4].

Bipartisan Support and Implementation Timeline

The bill has garnered bipartisan support, with ATA Action actively engaging with lawmakers on Capitol Hill this week to advance the legislation [1]. The timing is particularly significant as it aligns with the inclusion of PDTs in the 2025 Physician Fee Schedule [2]. The American Telemedicine Association’s advocacy arm has emphasized the legislation’s potential to close critical gaps in care for Medicare and Medicaid populations [5].

Bronnen

Digital Therapeutics Prescription